Health Condition 1: null- Diabetic Foot Ulcers Health Condition 2: E115- Type 2 diabetes mellitus with circulatory complications
Conditions
Interventions
Intervention1: Warm oxygen topical therapy for non healing diabetic foot ulcers: This is a pilot interventional study designed to analyze the effect of warm oxygen which is 33 percent more than body t
Sponsors
Yostra Labs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subject has a documented diagnosis of Diabetes mellitus â?? Type 1 or type 2 2) Leg ulcers with duration of more than 6 weeks but no longer than 1 year 3) Wound type â?? Chronic wound ulcer, Wagner-Meggit Grade 2, 3 4) Wound size range: greater than or equal to 25 sq. cm and less than or equal to 150 sq. cm 5) In case of multiple ulcers, only the largest is considered in the study (index ulcer) 6) Index ulcer must be greater than or equal to 1 cm away from any other ulcers present on the foot 7) Adequate perfusion with ABI greater than 0.7
Exclusion criteria
Exclusion criteria: 1) Peripheral vascular disease (PVD) - Arterial disease that is untreated 2) Evidence of gangrene of any part of the affected limb 3) Documented evidence of osteomyelitis on any part of affected limb 4) Index ulcer has exposed bone 5) Index ulcer exhibits signs of severe clinical infection that requires hospitalization or immediate surgical intervention 6) Active Charcot foot on the study limb 7) Uncontrolled diabetes: HbA1c > 10 % 8) Renal dialysis or creatinineine > 2.0 9) Active treatment of malignancy (not specific to study limb) and patients on immunosuppresants 10) Patient has a Deep Vein Thrombosis within the last 30 days 11) Subject has received heat or oxygen therapy for the index wound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Comparison of change in the wound area from baseline to final follow-up (12 weeks) in the intervention arm 2. Proportion of planned home visits that were successfully completed by the research associateTimepoint: 1.Baseline and 12 weeks 2.12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects if anyTimepoint: All the follow-up timepoints;Amputation rates over a 12 week follow-up periodTimepoint: 12 weeks;Mean wound area compared between intervention and control groups at 12 weeks follow-upTimepoint: 12 weeks;Quality of life measured using the IVDP Wound-QoL questionnaireTimepoint: 12 weeks;Rate of wound healing change in wound area from baseline to 12 weeks compared between 2 groupsTimepoint: Baseline 6 weeks 9 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Deepak Kamath
St Johns National Academy of Health Science
Outcome results
None listed